MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for BONE MALLET HEAVYWEIGHT 250-405 manufactured by Jarit/integra.
[103406296]
During a procedure, the head from the mallet detached from the handle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076002 |
| MDR Report Key | 7365253 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-21 |
| Date Added to Maude | 2018-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE MALLET HEAVYWEIGHT |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2018-03-22 |
| Catalog Number | 250-405 |
| Lot Number | 100132-1512 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT/INTEGRA |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-22 |